Prescription drug · ANDA
Phenylephrine Hydrochloride NDC 69315-324
Phenylephrine hydrochloride 100 mg/mL · Solution · Ophthalmic · Leading Pharma, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69315-324-05 | 6931503240569315032405 | 1 BOTTLE, DROPPER in 1 CARTON (69315-324-05) / 5 mL in 1 BOTTLE, DROPPERMarketed from Sep 5, 2024 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Phenylephrine Hydrochloride
- Generic name (nonproprietary)
- phenylephrine hydrochloride
- Active ingredients
- Phenylephrine hydrochloride — 100 mg/mL
- Dosage form
- Solution
- Route
- Ophthalmic
- Labeler
- Leading Pharma, LLCNDC labeler code 69315
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215183
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha1-Agonists (Mechanism)
- Identifiers
- Product ID 69315-324_a73191de-c6e0-455f-8e26-f90a529cac56SPL ID a73191de-c6e0-455f-8e26-f90a529cac56SPL set ID 7543f7e8-fd5f-46d5-a310-ebae71becf44RxCUI 1234571, 1234579UNII 04JA59TNSJUPC 0369315324059, 0369315323083, 0369315323151
- Pharmacologic class
- alpha-1 Adrenergic Agonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Ophthalmic products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N469315032405followed by a unit qualifier and the quantityPackage 69315-0324-05. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10%, is indicated to dilate the pupil. Phenylephrine Hydrochloride Ophthalmic Solution is an alpha-1 adrenergic receptor agonist indicated to dilate the pupil (1)
Excerpt only. Read the full label for complete information.
About NDC 69315-324
- What is NDC 69315-324?
- 69315-324 is the product NDC for Phenylephrine Hydrochloride, Phenylephrine hydrochloride 100 mg/mL solution, listed with the FDA by Leading Pharma, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Phenylephrine Hydrochloride.
- What is the active ingredient?
- Phenylephrine hydrochloride.
- Who is the labeler?
- Leading Pharma, LLC, NDC labeler code 69315. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Phenylephrine Hydrochloride?
- 107 other product NDCs are listed under this name. See all Phenylephrine Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Phenylephrine Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Phenylephrine Hydrochloride | Phenylephrine hydrochloride 25 mg/mL | Solution/ dropsOphthalmic | First Nation Group, LLC | 81469-168 | 81469-0168-0281469-0168-15 |
| Phenylephrine Hydrochloride | Phenylephrine hydrochloride 100 mg/mL | Solution/ dropsOphthalmic | First Nation Group, LLC | 81469-169 | 81469-0169-05 |
| Phenylephrine Hydrochloride | Phenylephrine hydrochloride 10 mg/mL | InjectionIntravenous | Fresenius Kabi USA, LLC | 65219-388 | 65219-0388-01 |
| Phenylephrine Hydrochloride | Phenylephrine hydrochloride 10 mg/mL | InjectionIntravenous | Caplin Steriles Limited | 65145-115 | 65145-0115-25 |
| Phenylephrine Hydrochloride | Phenylephrine hydrochloride 50 mg/5mL | InjectionIntravenous | Caplin Steriles Limited | 65145-116 | 65145-0116-0165145-0116-10 |
| Phenylephrine Hydrochloride | Phenylephrine hydrochloride 100 mg/10mL | InjectionIntravenous | Caplin Steriles Limited | 65145-117 | 65145-0117-01 |
| phenylephrine hydrochloride | Phenylephrine hydrochloride 10 mg/mL | InjectionIntravenous | Baxter Healthcare Corporation | 36000-358 | 36000-0358-25 |
| phenylephrine hydrochloride | Phenylephrine hydrochloride 10 mg/mL | InjectionIntravenous | Baxter Healthcare Corporation | 36000-360 | 36000-0360-10 |
| phenylephrine hydrochloride | Phenylephrine hydrochloride 10 mg/mL | InjectionIntravenous | Baxter Healthcare Corporation | 36000-362 | 36000-0362-05 |
| Phenylephrine Hydrochloride | Phenylephrine hydrochloride 10 mg/mL | InjectionIntravenous | Method Pharmaceuticals, LLC | 58657-851 | 58657-0851-26 |
Other NDCs under ANDA 215183
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Phenylephrine Hydrochloride | Phenylephrine hydrochloride 25 mg/mL | Solution/ dropsOphthalmic | Caplin Steriles Limited | 65145-148 |
| Phenylephrine Hydrochloride | Phenylephrine hydrochloride 25 mg/mL | Solution/ dropsOphthalmic | Caplin Steriles Limited | 65145-149 |
| Phenylephrine Hydrochloride | Phenylephrine hydrochloride 100 mg/mL | Solution/ dropsOphthalmic | Caplin Steriles Limited | 65145-150 |
| Phenylephrine Hydrochloride | Phenylephrine hydrochloride 25 mg/mL | SolutionOphthalmic | Leading Pharma, LLC | 69315-323 |
| Phenylephrine Hydrochloride | Phenylephrine hydrochloride 25 mg/mL | Solution/ dropsOphthalmic | SOLA Pharmaceuticals, LLC | 70512-865 |
| Phenylephrine Hydrochloride | Phenylephrine hydrochloride 100 mg/mL | Solution/ dropsOphthalmic | SOLA Pharmaceuticals, LLC | 70512-866 |